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RU-486 -- Dispelling the Myths

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Oct. 6, 2000 (Washington) -- The FDA's approval of RU-486, or Mifeprex, has renewed the abortion issue as a topic of national debate and highlighted abortion as a presidential campaign issue. But mixed in with discussion of the approval of RU-486 are a number of myths:

Myth #1 -- The FDA timed the approval to become an issue in the presidential campaign.

Not so. The FDA had to decide on whether to approve or reject RU-486 by the end of September of this year because the law requires the agency to make approval decisions within certain time frames. It just so happened that the time frame expired in the midst of the campaign.

That's not to say that the FDA did not recognize the implications of its decision. What has not been widely reported is that the FDA itself, under its former Commissioner David A. Kessler, actually initiated the RU-486 approval by asking its manufacturer to submit the application. I can't recall any other instance in which a FDA Commissioner has invited a drug company to apply for a specific product approval.

The approval of a new abortion option had a lot of support within the FDA staff, but they tried to make the decision on the basis of the scientific data demonstrating RU-486's safety and efficacy.

Myth #2 -- The approval of RU-486 can easily be reversed by the next presidential administration.

Not so. Even though the FDA reports ultimately to the White House, a drug approval has a legal standing that cannot be simply and quickly overturned. For RU-486 to be taken off the market, the FDA would have to go through a lengthy legal/administrative process that could take years.

The reason that some drugs, such as the weight loss drug Redux, have come off the market so quickly was because manufacturers usually voluntarily withdraw drugs that the FDA deems unsafe. The manufacturer of RU-486 would not be so cooperative with an anti-abortion rights administration, and if an effort is made to remove the drug, a legal and lengthy fight is likely to ensue. Thus, if George W. Bush, who has expressed opposition to RU-486's approval, were to be elected president, and were he to seek removal of RU-486, he cannot do it on command.